Probiotic for Radiation Injury

Overseen By UCCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Cincinnati

Must not be taking: Investigational agents

Disqualifiers: IBD, Prior pelvic radiation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a probiotic called Pendulum Glucose Control (PGC) can reduce stomach and bowel issues for patients undergoing pelvic radiation therapy. The goal is to determine if these probiotics can ease the digestive side effects of radiation treatment. The trial seeks participants with certain types of cancer, such as lower gastrointestinal, gynecologic, or prostate cancer, who are scheduled for pelvic radiation therapy. Participants should not have inflammatory bowel diseases like Crohn's or Ulcerative Colitis and must be able to swallow capsules. As an Early Phase 1 trial, this research focuses on understanding how PGC works in people, offering participants the chance to contribute to groundbreaking insights.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that Pendulum Glucose Control (PGC) is likely to be safe for humans?

Research has shown that Pendulum Glucose Control (PGC), a probiotic taken orally, has been tested in earlier studies for safety and effectiveness. In these studies, adults with type 2 diabetes and stomach issues received PGC, and most tolerated it well. Another study on Pendulum's formula found it helped lower blood sugar levels without major side effects.

Additionally, a study on women receiving pelvic radiation therapy found that a similar probiotic did not cause harmful effects and suggested it might help reduce diarrhea during treatment.

While these studies are promising, the current trial is in its early stages. The main goal is to determine if the probiotic is safe for people undergoing pelvic radiation. Early trials often focus on safety, so more information will help confirm how well PGC is tolerated during radiation therapy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for radiation injury that typically involve medications to manage symptoms or promote healing, Pendulum Glucose Control (PGC) is a probiotic, which means it uses live bacteria to potentially improve health. Researchers are excited because PGC may offer a new way to enhance recovery by targeting the gut microbiome, which plays a crucial role in the body's response to radiation. This approach not only represents a novel mechanism of action but also offers a more natural alternative that could work alongside existing therapies to improve patient outcomes.

What evidence suggests that Pendulum Glucose Control might be an effective treatment for radiation injury?

Research has shown that Pendulum Glucose Control (PGC) probiotics may help reduce stomach and digestive issues. Although PGC primarily manages blood sugar levels, it also supports gut health. One study found that PGC lowered blood sugar spikes after meals by 33%. In this trial, participants will receive a combination of PGC probiotics and radiation therapy. Probiotics may enhance the effectiveness of radiation therapy and reduce its harm, suggesting that PGC could lessen digestive side effects during pelvic radiation therapy by promoting a healthy gut. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients undergoing pelvic radiation therapy who may experience gastrointestinal toxicity. Specific eligibility criteria are not provided, but typically participants would need to be receiving pelvic RT and able to take oral medication.

Inclusion Criteria

I am 18 years old or older.

Ability to understand and the willingness to sign a written informed consent document

My cancer diagnosis is one that requires radiation to the pelvic lymph nodes.

Exclusion Criteria

Known inulin intolerance or allergies or hypersensitivity to any of the components of PGC

I cannot swallow capsules.

Absolute Neutrophil Count (ANC) < 1500/uL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pendulum Glucose Control (PGC) probiotic alongside pelvic radiation therapy

10 weeks

Visits at baseline, week 4, week 6, and week 10

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 30-day safety visit

4 weeks

1 visit (in-person) at week 14

What Are the Treatments Tested in This Trial?

Interventions

• Pendulum Glucose Control (PGC)

Trial Overview The study is testing the safety and effectiveness of an oral probiotic called Pendulum Glucose Control (PGC) in reducing gastrointestinal side effects during pelvic radiation therapy.

How Is the Trial Designed?

Group I: RT + Probiotic Experimental Treatment 1 Intervention

Pendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Pendulum Therapeutics

Industry Sponsor

Trials

7

Recruited

370+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9606548/

A New Medical Probiotic Formulation for the Nutritional ... This probiotic blend product marketed for glucose control is unlikely to be harmful and may be helpful in lowering postprandial blood glucose and A1C levels.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04228003

Pendulum D2D Glucose Control for Adults With Type 2 ... The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints

3. pendulumlife.com pendulumlife.com/pages/research-clinical-trials?srsltid=AfmBOoo2QXgxYLvS-DCqj6LFQBvz6q-ctQxjrtrlYPcXYThNOK7kKYo5

Clinical Trials | Pendulum's Research The study:This investigator-initiated clinical trial evaluates the effects of Pendulum Glucose Control in preventing bone loss among women with early-stage ...

4. microbiometimes.com microbiometimes.com/pendulum-therapeutics-announces-publication-of-clinical-data-for-first-ever-medical-probiotic-that-provides-the-dietary-management-of-healthy-a1c-and-blood-glucose-levels/

Pendulum Therapeutics Announces Clinical Data For ... At 12 weeks, the data showed that those who received Pendulum's formulation experienced a 33 percent decrease in post-meal blood glucose spikes ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264922/

Microbiome in radiotherapy: an emerging approach to ... This paper aims to provide an overview of the human microbiome and its role in augmenting radiation effectiveness while minimizing damage.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07231588?aggFilters=status%3A%2CfunderType%3Aindustry

Oral 5 Strain Probiotic for GI Toxicity Mitigation During ... This research is to determine if an oral probiotic, Pendulum Glucose Control (PGC), can be safely given to patients during pelvic radiation ...

7. pendulumlife.com pendulumlife.com/blogs/news/pendulum-therapeutics-announces-publication-of-clinical-data-for-first-ever-medical-probiotic-that-provides-the-dietary-management-of-healthy-a1c-and-blood-glucose-levels?srsltid=AfmBOool0hILE0-rikYqaBVr6RsLp37dxWd3znD-NbFQ2o93UNQyPle6

Pendulum Therapeutics Announces Publication Of Clinical ... At 12 weeks, the data showed that those who received Pendulum's formulation experienced a 32.5 percent decrease in post-meal blood glucose ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9723296/

Decreasing the Adverse Effects in Pelvic Radiation Therapy The primary endpoint was the probiotic effect on the mean number of loose stools during radiation therapy. Results. Of the 97 randomized women, 75 provided data ...